Long-term Safety and Efficacy of Empagliflozin as Add on to GLP-1 RA

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A 52-week Randomised, Double-blind, Parallel Group, Safety and Efficacy Study of Empagliflozin Once Daily as add-on Therapy to Glucagon-like Peptide-1 Receptor Agonist in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02589626
• Other study ID #: 1245.106
• Status: Completed
• Phase: Phase 4
• Start date: October 29, 2015
• Est. completion date: June 2, 2017

Study information

• Verified date: January 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2, 2017
• Est. primary completion date: June 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion criteria:

• Diagnosis of type 2 diabetes mellitus

• Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day alone for at least 10 weeks prior to screening must be >=7.0% and <=10.0% at screening

• Male and female patients on diet and exercise regimen who are pre-treated with Liraglutide at 0.9 mg/day and one of oral antidiabetic drug (OAD) for at least 10 weeks prior to Visit 1 must be >=7.0% and <=9.0% at screening and >=7.0% and <=10.0% at placebo run-in

• Male and female patients on diet and exercise regimen who are pre-treated with OAD alone for at least 10 weeks prior to Visit 1 must be >=7.0% and <=10.0% at both screening and placebo run-in

• Age at informed consent must be >=20 years

• BMI at screening must be <=40 kg/m2

• Further inclusion criteria apply

Exclusion criteria:

• Uncontrolled hyperglycaemia with a glucose values >270 mg/dL (>15.0 mmol/L) after an overnight fast during switch/washout/placebo run-in period and confirmed by a second measurement

• Patients who are drug-naïve at screening visit or treat with any of insulin, thiazolidine dione, sodium-glucose co-transporter 2 (SGLT-2) inhibitor within 10 weeks prior to informed consent.

• Acute coronary syndrome, stroke or transient ischemic attack within 12 weeks prior to informed consent

• Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal as determined during screening and/or switch/washout/placebo run-in period

• Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 (Japanese equation) as determined during screening and/or switch/washout/placebo run-in period

• Further exclusion criteria apply

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• empagliflozin 10mg

• empagliflozin 25 mg

• Placebo
For blinding purposes

Locations

Country	Name	City	State
Japan	Kunisaki Makoto Clinic	Fukuoka, Fukuoka
Japan	Seino I.M. Clinic, Fukushima, I.M.	Fukushima, Koriyama
Japan	Nippon Kokan Fukuyama Hospital	Hiroshima, Fukuyama
Japan	Nakakinen Clinic	Ibaraki, Naka
Japan	Kubota Clinic	Kanagawa, Kawasaki
Japan	Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic	Kanagawa, Yamato-shi
Japan	Yokohama Minoru Clinic	Kanagawa, Yokohama
Japan	Yokkaichi Diabetes Clinic	Mie, Yokkaichi
Japan	Shiraiwa Medical Clinic	Osaka, Kashiwara-shi
Japan	AMC Nishi-umeda Clinic	Osaka, Osaka-shi
Japan	OCROM Clinic	Osaka, Suita
Japan	Fukuwa Clinic	Tokyo, Chuo-ku
Japan	Tokyo-Eki Center-building Clinic	Tokyo, Chuo-ku
Japan	Minamino Heart Clinic	Tokyo, Hachioji
Japan	Shinjuku Research Park Clinic	Tokyo, Shinjuku-ku
Japan	ToCROM Clinic	Tokyo, Shinjuku-ku

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment	Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented	52 weeks
Secondary	Change From Baseline in HbA1c After 52 Weeks of Treatment	Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means.	baseline and 52 weeks

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